Robust and proven quality and management system that encompasses the essential elements necessary for the design, production, and distribution for innovative medical devices that meet today’s challenging healthcare and cost containment needs. Our products help with the correct policies for class 1, class 2, and class 3 medical devices.
Medical Device triggers include:
- Each device is designed for specific function and needs a tailored product coverage depending on if it a class 1, 2 or 3 device.
- Navigate the fda 510 k regulation process
- Human Clinical trials liability with protection for coordination of global clinical trial activity
- Diagnostic Analysis. identify the type and frequency of products liability incidents that are known to be associated with the particular products you manufacture.
- Gap Analysis. determine the efficacy of your existing product safety management controls and where they can be enhanced.
- Summary & Recommendations. provide a written summary of findings and recommend controls that can build into operations to correct any deficiencies that could otherwise lead to products liability losses.
- Product Recall Expenses Coverage reimburses the named insured for certain product recall expenses directly attributable to a class I recall of medical or biotechnology products from the coverage territory. The recall must be initiated by the named insured during the policy period and the products must have been physically relinquished to others.
- Security Breach Notification and Remediation Expenses Coverage reimburses the named insured for certain expenses directly attributable to a security breach that is caused by an information security wrongful act.
- Crisis Management Service Expenses Coverage reimburses the named insured for certain expenses incurred to mitigate negative publicity directly attributable to a covered errors and omissions wrongful act or covered information security wrongful act.
- Clinical Trial Medical Expenses Coverage provides payment for “medical expenses” for “bodily injury” included in the “products-completed operations hazard” regardless of fault. The bodily injury must arise out of the injured person’s participation as a human subject in a “clinical trial.”